Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02048514




Registration number
NCT02048514
Ethics application status
Date submitted
27/01/2014
Date registered
29/01/2014
Date last updated
9/03/2021

Titles & IDs
Public title
The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
Scientific title
The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
Secondary ID [1] 0 0
N09-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysms 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Nellix Aneurysm Sealing - The Nellix® EndoVascular Aneurysm Sealing System
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety- Number of Major Adverse Events
Assessment method [1] 0 0
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.
Timepoint [1] 0 0
30 day
Primary outcome [2] 0 0
Device Performance
Assessment method [2] 0 0
The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
All Cause Mortality
Assessment method [1] 0 0
Any death occurring during the study period, regardless of cause
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* At least 18 years of age
* Informed consent form understood and signed and patient agrees to all follow-up visits
* Is able and willing to comply with clinical follow-up requirements for one year
* Is able and willing to undergo Contrast-Enhanced Spiral CT scans
* Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;

1. aneurysm = 4.5 cm in diameter, or
2. aneurysm is twice the diameter of the normal infrarenal aorta, or
3. aneurysm is growing at a rate of = 10 % per year
* Non-aneurysmal aortic neck length = 5mm below the most inferior renal artery
* Proximal aortic neck diameter between 16 and 36mm
* Aortic neck angulation to the sac = 60
* Common iliac artery diameter 8 to 35mm bilaterally
* Aneurysm blood lumen diameter = 60mm
* Iliac and femoral arteries suitable for endovascular access with the Nellix System
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Life expectancy = 1 year
* Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
* Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
* Thoracic aneurysm = 4.5cm in diameter
* AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
* Presence of mural thrombus > 50% circumferentially in aortic neck
* Iliac aneurysm blood lumen diameter > 35mm
* Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure
* History of prior treatment of abdominal aortic or iliac artery aneurysm disease
* Femoral or iliac artery occlusive disease such that device delivery is not possible
* Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft
* Receiving dialysis
* History of hypercoagulability
* Allergy to IV contrast
* Serum creatinine level >2.0 mg/dL (or equivalent)
* Patient is pregnant or nursing
* Patient is currently enrolled in an investigational drug or device trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Cali
Country [2] 0 0
Latvia
State/province [2] 0 0
Riga
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Venezuela
State/province [4] 0 0
Caracas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endologix
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02048514